What changed between the draft committee report and the plenary report

Change 31

Added:SHORT JUSTIFICATION

Added:The sustainability and resilience of agriculture and of the entire food chain are largely based on the diversity and quality of seeds and other plant reproductive material (PRM). The main aim of this legislative proposal is to draw up a single regulation with a coherent framework encompassing the provisions hitherto included in 10 separate Directives.

Added:In order to ensure the quality of PRM and consumer confidence, the rules on PRM production and marketing must be based on categorisation and protocols drawn up and monitored by the relevant authorities. Over and above those basic principles, a number of delegated and implementing acts will be drawn up to clarify and adapt the implementation arrangements to the broad diversity of PRM. In line with the principle of proportionality and farmers’ right to use their own seeds and other PRM, farmers must not be required to follow the principles set out in this proposal that apply solely to the production of PRM to be placed on the market as PRM rather than for other purposes, such as food. Your rapporteur also believes that farmers should have a derogation for seed and PRM exchanges, including when they receive payment for costs incurred.

Added:Derogations should also be included to facilitate the conservation of certain PRM, recognise the specific characteristics of heterogeneous PRM, adapt the restrictions for sales to non-professional buyers, and recognise the special nature of gene banks and other conservation organisations. Your rapporteur believes, in particular, that heterogeneous material provides crucial pools of genetic diversity for climate change mitigation and that this therefore justifies opening up this category to all species so that they might be included. However, it is necessary, more generally, to exclude from the various derogations PRM consisting of genetically modified organisms or NGT plants.

Added:In order to be registered as a variety, the distinctness, uniformity and stability of the PRM must be verified. In its proposal, the Commission proposes including a complementary technical test of the value for sustainable cultivation and use (VSCU), which should confirm that a variety offers a ‘clear improvement’ compared to other varieties that are already registered. Your rapporteur believes that the value of a variety depends, first and foremost, on the conditions in which it develops and has been bred: a variety cannot be considered to be sustainable in itself as everything depends on the agricultural production system using it. That is why VSCU should be tested in different production methods, notably where synthetic pesticides are not used, as in organic farming. Moreover, VSCU testing should not result in varieties being excluded if that reduces crop biodiversity. VSCU testing should also be optional for fruits and vegetables because of the costs involved for small and medium-sized seed producers.

Added:Finally, your rapporteur believes that the legislative proposal on PRM requires an amendment of Directive 98/44/EC on the legal protection of biotechnological inventions in order to maintain free access to genetic resources. To avoid destabilising the system of plant variety rights, which ensures fair remuneration for breeders without curbing access to innovation, PRM obtained from new genomic techniques (NGT) should not be patentable. Patents should only be extended to include the organic material derived therefrom. Finally, the scope of compulsory licensing should be widened in the case of a proven environmental or economic benefit.

Added:AMENDMENTS

Added:The Committee on the Environment, Public Health and Food Safety calls on the Committee on Agriculture and Rural Development, as the committee responsible, to take into account the following amendments:

Added:Recital 5: (5) In order to achieve this transition to sustainable food systems, the Union legislation should therefore take account of the need to ensure the adaptability and diversity of PRM to the changing agricultural, horticultural and environmental conditions, to face the challenges of climate change, to protect and restore biodiversity and to meet increasing farmers’ and consumers’ expectations related to quality, resilience and sustainability of PRM.

Added:Recital 36 a (new): (36 a) The Regulation should strive for the 'One Health Approach’ as an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, plants and ecosystems. It recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent;

Added:Recital 38 a (new): (38 a) Heterogeneous material should not consist of a GMO or a category 1 or category 2 NGT plant as defined in Regulation (EU).../...

Added:Recital 49: (49) In order to contribute to the sustainability of agricultural production and food systems while recognising that sustainability cannot be reduced to a single trait or variety but can only apply to a cultivated system as a whole, and in order to serve economic, environmental and broader societal needs, new varieties of all genera or species should show an improvement compared to the other varieties of the same genera or species registered in the same national variety register, concerning certain aspects. Among those aspects are their yield, including yield stability and yield under low input conditions; tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses, insects and other pests; tolerance/resistance to abiotic stresses, including adaptation to climate change conditions; more efficient use of natural resources, such as water and nutrients; reduced need for external inputs, such as plant protection products and fertilisers; characteristics that enhance the sustainability of storage, processing and distribution; and quality or nutritional characteristics (‘value for sustainable cultivation and use’). For the purpose of deciding on the variety registration and in order to provide sufficient flexibility to register varieties with the most desirable characteristics, those aspects should be considered for a given variety as a whole.

Added:Recital 64: deleted

Added:Article 1 – paragraph 1: This Regulation lays down rules for the production of plant reproductive material (‘PRM’) with a view to its marketing as PRM in the Union, and in particular requirements for the production of PRM in the field and other sites, categories of material, identity and quality requirements, certification, labelling, packaging, imports, professional operators and the registration of varieties.

Added:Article 2 – paragraph 1 – subparagraph 3: The requirements concerning production of PRM shall apply only to production with a view to its marketing as PRM in the EU.

Added:Article 2 – paragraph 2 – point a: (a) to ensure quality and diversity of choice for PRM, and its availability for professional operators, farmers and final users;

Added:Article 2 – paragraph 2 – point b: (b) to ensure appropriate conditions for the competition of the professional operators across the Union and the functioning of the internal market in PRM;

Added:Article 2 – paragraph 2 – point d: (d) to contribute to the dynamic conservation and sustainable use of plant genetic resources and agro-biodiversity;

Added:Article 2 – paragraph 2 – point e: (e) to contribute to sustainable and productive food systems, adapted to diverse climatic and soil conditions, for current and future projected climatic conditions;

Added:Article 2 – paragraph 2 – point f: (f) to contribute to food security and food sovereignty.

Added:Article 2 – paragraph 4 – point e: (e) PRM sold or transferred in any other way, whether free of charge or not, for official testing, breeding, inspections, exhibitions or scientific purposes, including for on-farm research and for activities carried out in the framework of the dynamic conservation of genetic resources;

Added:Article 2 – paragraph 4 – point e a (new): (e a) PRM produced by farmers for their own use;

Added:Article 3 – paragraph 1 – point 29 – point a: (a) traditionally grown or locally newly bred or developed under specific local conditions, and adapted to those conditions or the utilisation in a marginal environment or production system; and

Added:Article 3 – paragraph 1 – point 29 – point a a (new): (aa) not an F1 hybrid; and

Added:Article 3 – paragraph 1 – point 29 – point b: (b) in the case of seeds, can be characterised by a certain level of genetic and phenotypical diversity between individual reproductive units

Added:Article 3 – paragraph 1 – point 35 a (new): (35 a) Plant breeding means activities and practices involved in developing new plant varieties and their selection prior to application for registration;

Added:Article 3 – paragraph 1 – point 35 b (new): (35 b) ‘dynamic conservation of plant genetic resources’ means activities carried out by gene banks, community seed banks and other organisations and networks, as well as their members and individual seed savers, implying transfers of PRM in both formal and informal ways, whether or not for consideration and seeking to contribute to the long-term conservation and enrichment of plant genetic diversity.

Added:Article 5 – paragraph 1 – point e: (e) as PRM exchanged between farmers in accordance with Article 30;

Added:Article 6 – paragraph 2 – point d: (d) as PRM exchanged between farmers in accordance with Article 30;

Added:Article 22 – paragraph 1 – subparagraph 1 – point c a (new): (c a) it is not covered by an intellectual property right limiting its use for conservation purposes.

Added:Article 22 – paragraph 1 – subparagraph 1 – point c b (new): (cb) it does not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) or of a category 1 or 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation ...).

Added:Article 26 – paragraph 1: 1. By way of derogation from Article 20, PRM of all genera or species listed in Annex I belonging to a conservation variety registered in a national variety register referred to in Article 44(1), point (b), may be produced and marketed in the Union as standard seed or material, if it complies with all the requirements concerning standard seed and material for the respective species, as referred to in Article 8.

Added:Article 26 – paragraph 2 a (new): 2 a. A variety of conservation, its parts and/or its genetic components may not be covered by an intellectual property right limiting its use for conservation, research, breeding and/or training, including on-farm participatory research and breeding.

Added:Article 27 – paragraph 3 – subparagraph 2: Those amendments shall be developed in consultation with respective multi actor stakeholders involved in heterogeneous material in order to adapt to the development of the respective technical and scientific evidence, and the international standards, and to follow up on the experience gained by the application of this Article concerning all species.

Added:Article 27 – paragraph 4: 4. Any professional operator producing and/or intending to market PRM of heterogeneous material shall submit a notification to the competent authority prior to marketing. If no further information is requested by the national competent authority within three months, the PRM of heterogeneous material may be marketed.

Added:Article 27 – paragraph 7 – subparagraph 1: Heterogeneous material as notified pursuant to paragraph 1, shall be registered by the competent authorities in a dedicated register (‘heterogeneous material register’). Registration shall be free of charge.

Added:Article 29 – title: PRM marketed by, to, within and between organisations and networks dedicated to the dynamic conservation and sustainable use of plant genetic resources

Added:Article 29 – paragraph 1 – subparagraph 1: By way of derogation from Articles 5 to 25, PRM may be marketed by, to, within, or between organisations and networks, including farmers, dedicated to the dynamic conservation and sustainable use of plant genetic resources whereby any of the activities are carried out for non-profit purposes.

Added:Article 29 – paragraph 1 – subparagraph 2: It can be marketed as well from those conservation organisations and networks or their members to persons who carry out dynamic conservation of that PRM as final consumers, or for professional farming purposes.

Added:Article 29 – paragraph 1 – subparagraph 3 – introductory part: In the cases provided for in the first and the second subparagraphs, conservation organisations and networks shall not fulfil the obligations under Article 41 to 43, and PRM shall be listed in a register kept by those conservation organisations and networks with a basic description of that PRM.

Added:Article 29 – paragraph 1 – subparagraph 3 – point a: deleted

Added:Article 29 – paragraph 1 – subparagraph 3 – point b: deleted

Added:Article 29 – paragraph 1 – subparagraph 3 – point c: deleted

Added:Article 29 – paragraph 2: deleted

Added:Article 30 – title: PRM exchanged between farmers

Added:Article 30 – paragraph 1 – introductory part: 1. By way of derogation from Articles 5 - 25, farmers may exchange PRM in kind or for monetary compensation covering direct costs incurred, if such PRM fulfils all of the following conditions:

Added:Article 30 – paragraph 1 – point 3: (3) are not subject to a service contract for multiplication conducted by the respective farmer with a professional operator performing PRM production; and

Added:Article 30 – paragraph 1 – point 4: (4) the PRM is used for dynamic management of farmer’s own PRM for the purpose of contributing to agro-diversity.

Added:Article 30 – paragraph 2 – introductory part: 2. Such PRM shall fulfil all of the following requirements:

Added:Article 30 – paragraph 2 – point a: (a) not to belong to a to variety for which plant variety rights have been granted in accordance with Regulation (EU) 2100/94 and where the right is still in force;

Added:Article 30 – paragraph 2 – point b: (b) to be limited to small quantities defined by the competent authorities sufficient to meet the own needs of a farmer for specific species per year, without using commercial intermediaries or public offer of marketing; and

Added:Article 30 – paragraph 2 – point c: (c) to be practically free from quality pests and any defects likely to impact their quality as PRM.

Added:Article 30 – paragraph 3: deleted

Added:Article 32 – paragraph 1 – subparagraph 2 a (new): This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Added:Article 33 – paragraph 4 a (new): 4a. This exceptional authorisation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Added:Article 35 – paragraph 1 – point c: (c) the requirements set out in paragraphs 2 to 5a are fulfilled.

Added:Article 35 – paragraph 5 a (new): 5 a. This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Added:Article 37 – paragraph 1 – subparagraph 1: Where there are reasonable grounds to suspect that the production or marketing of PRM could constitute a serious risk to human, animal or plant health, environment or cultivation of other species, and such risk cannot be contained satisfactorily by means of measures taken by the Member State concerned, the Commission shall take, without delay, by means of implementing acts, any appropriate interim emergency measures. Such measures shall be limited in time. They may include provisions restricting or prohibiting the marketing of the PRM concerned or laying down appropriate conditions for its production or marketing, depending on the gravity of the situation.

Added:Article 37 – paragraph 1 – subparagraph 1 a (new): By means of derogation from the first subparagraph, in case of lack of compliance with refuge requirements or with other requirements imposed on cultivation of varieties containing or consisting of genetically modified organisms , the measures restricting or prohibiting the marketing of the PRM concerned shall be put in place until full compliance is restored.

Added:Article 41 – paragraph 1 a (new): The activities referred to in Articles 28, 29 and 30 shall not be subject to the provisions of this article.